Elastomeric stopper sterilization system
Ensure sterilization and cleanliness of elastomeric vial stoppers with a system designed for seamless integration into your production line, optimizing processes from washing to unloading.
The Elastomeric Stopper Treatment Autoclave System by Fedegari automates the entire process of treating elastomeric vial stoppers, providing pharmaceutical manufacturers with a robust solution that combines washing, rinsing, siliconizing, sterilizing, drying, and automatic unloading. Employing a dual-purpose design, the system functions as both a stopper treatment unit and a steam sterilizer, ensuring versatile application within production lines. The process utilizes Thema4 control system for precise operation, while the rotating drum with magnetic coupling ensures unimpeded chamber space. Suitable for biopharmaceutical and pharmaceutical industries, it supports batch and continuous operations, handling both solid and powder product types. The system is constructed from AISI 316L stainless steel for maximum corrosion resistance and complies with GMP, FDA, and various international standards, reinforcing its suitability for sterile environments. Its ease of integration and adaptability to customer-specific needs make it an invaluable asset in maintaining aseptic conditions and optimizing stopper processing workflows.
Benefits
- Enhances sterility assurance by integrating washing, sterilizing, and unloading processes.
- Increases operational efficiency with dual-purpose functionality as both a stopper treatment unit and steam sterilizer.
- Customizable chamber sizes accommodate varying production needs, maximizing throughput.
- Facilitates seamless integration into existing cleanroom operations with Thema4 control and automation.
- Ensures compliance with international standards, including GMP and FDA, for validated sterilization processes.
- Applications
- Biopharmaceuticals,Vials,Pharmaceutical products,Stoppers
- End products
- Sterile pharmaceutical containers,Elastomeric vial stoppers,Biopharmaceutical vials,Injectable drug vials,Ready-to-use vial closures
- Steps before
- Washing,Rinsing
- Steps after
- Siliconizing,Drying,Packing
- Input ingredients
- elastomeric closures,stoppers,non-metallic components,porous materials,vials
- Output ingredients
- sterile elastomeric closures,washed stoppers,siliconized stoppers,sterilized stoppers,dried stoppers,sterile vials
- Chamber Material
- AISI 316L stainless steel
- Chamber Capacity
- 200 to 6,800 liters
- Surface Roughness
- Ra <0.4 μm
- Temperature Sensors
- 6 PT100 RTD
- Door Type
- Hinged opening system
- Cycle Processes
- Washing,rinsing,siliconizing,sterilizing,drying
- Automation System
- Thema4 process controller
- Unloading Options
- Semi-automatic door with auto-sterilizing chute
- Rotating Drum
- Magnetic coupling
- Operating Modes
- Dual-purpose
- Compliance,Certifications
- FDA,PED,GMP,GAMP5,ATEX,EN 285,ASME,etc.
- Automation level
- PLC / SCADA
- Batch vs. continuous operation
- Batch
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Integrated steps
- Washing,Rinsing,Siliconizing,Sterilizing,Drying,Unloading
- Working mechanism
- Rotating drum with magnetic coupling
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Elastomeric stopper material
- Synthetic rubber
- Container size and shape
- Customizable
- Process type
- Washing,siliconizing,sterilizing
- Product load type
- Stoppers
- Sterilization method
- Moist-heat
- Electromagnetic compatibility (EMC)
- 2014/30/EU
- Low tension equipment (LVD)
- 2014/35/EU
- Safety of machinery (MD)
- 2006/95/EC
- Pressure equipment directive (PED)
- 2014/68/EU
- FDA compliance
- compliance for non-metallic components in contact with process fluids
- UL 61010-1
- Safety requirements for electrical equipment for measurement,control and laboratory use – Part 1
- NFPA 70
- National electrical code
- ATEX certification
- 94/4/EC
- USP
- compliance for non-metallic components in contact with process fluids
- Chamber Material
- AISI 316L stainless steel
- Chamber Size
- 200 to 6,800 liters
- Chamber Surface Finish
- Mechanically polished,Ra <0.4 μm
- Door Type
- Hinged opening systems,semi-automatic door
- Rotating Drum
- Magnetic coupling,AISI 316L stainless steel
- Unloading Options
- Heat-sealed bags,stainless steel tanks
- Control System
- Thema4 process controller
- Control panel type
- Thema4 process controller
- Chamber size
- Customizable from 200 to 6,800 liters
- Unloading options
- Heat-sealed bags / Stainless steel tanks
- Drum type
- Rotating AISI 316L stainless steel drum
- Integration possibilities
- Integration with SCADA and MES systems
- Market info
- Fedegari is known for manufacturing high-quality sterilization and contamination control equipment for the pharmaceutical and biotech industries, offering engineered-to-order solutions with a strong reputation for innovation, reliability, and customer support.